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Can starting anemia drug sooner keep MDS patients off transfusions?

NCT ID NCT03223961

Symptom relief Sponsor: Groupe Francophone des Myelodysplasies Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether starting epoetin alfa early, as soon as anemia appears, works better than waiting until a person needs blood transfusions. The trial enrolls adults with lower risk myelodysplastic syndromes (MDS) who have mild anemia and are not yet dependent on red blood cell transfusions. Participants receive weekly epoetin alfa injections for at least 12 weeks, either right away or later when their hemoglobin drops to a pre-set threshold. The main goal is to see which approach delays the need for regular transfusions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
epoetin alfa, a hormone that stimulates red blood cell production
What this could lead to
If early treatment works, people with lower risk MDS and mild anemia might avoid or delay the need for regular blood transfusions.
What could go wrong
The trial may show no difference between starting early and waiting, or epoetin alfa may stop working over time. Some people do not respond to it at all, and it carries risks like blood clots and high blood pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 124 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2018

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years 2. MDS according to WHO 2016 criteria, with low or int 1 classical IPSS 3. Non-RBC transfusion dependent anemia 4. Hb level between 9 and 10.5g/dl (at the center's lab) 5. Hb level should be at least 1g/dl higher than the Hb threshold chosen to start RBC transfusions based on age, comorbidities and predicted clinical tolerance of anemia (this transfusion threshold should be chosen between 8 and 9g/dl) 6. Serum EPO level \<500U/l 7. No other cause of anemia (including iron deficiency, vitamin B12 or B9 deficiency, hemolysis, hypothyroidism….) 8. Performance status \<=2 Exclusion Criteria: 1. Higher risk MDS (IPSS intermediate-2 or high) 2. Del 5q 3. Baseline Hemoglobin level \> 10.5 g/dl or \<9g/dl 4. Transfusion threshold (based on age , comorbidities…) \>9g/dl 5. Transfusion threshold less than 1 g/dl below baseline Hb level 6. RBC transfusion dependence. Patients may have received only one transfusion series for MDS prior to inclusion 7. CMML , if \>10 % BM blasts or WBC\>13.000/mm3 8. Uncontrolled hypertension 9. Uncontrolled cardiovascular disease including angina pectoris or cardiac failure 10. Renal failure: Creatinine clearance\<40ml/min (using MDRD formula) 11. Pregnancy (positive bettaHCG) or nursing

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Conditions

The condition(s) this trial relates to.

myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelodysplastic syndromes

Contacts and locations

Locations

  • CH Angers

    Angers, 49 000, France

  • CH Avignon

    Avignon, 84000, France

  • CH Saint Nazaire

    Saint-Nazaire, 44600, France

  • CH Valence

    Valence, 26953, France

  • CH de Cholet

    Cholet, 49325, France

  • CH de Périgueux

    Périgueux, 24019, France

  • CH de Sevigné

    Cesson, 35510, France

  • CH de Troyes

    Troyes, 10003, France

  • CHR d'Annecy

    Pringy, 74374, France

  • CHRU Limoges

    Limoges, 87042, France

  • CHRU de Reims

    Reims, 51092, France

  • CHSF Gilles de Corbeil

    Corbeil-Essonnes, 91100, France

  • CHU Brabois

    Vandœuvre-lès-Nancy, 54511, France

  • CHU Estaing

    Clermont-Ferrand, 63000, France

  • CHU Pontchaillou

    Rennes, 35033, France

  • CHU de Besançon

    Besançon, 25030, France

  • CHU de Caen

    Caen, 14033, France

  • CHU de Grenoble

    Grenoble, 38043, France

  • CHU de Nantes

    Nantes, 44093, France

  • CHU de Nice

    Nice, France

  • CHU de Poitiers

    Poitiers, 86021, France

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Hospitalier Joffre-Perpignan

    Perpignan, 66046, France

  • Centre Hospitalier Lyon Sud

    Lyon, 69495, France

  • Centre Hospitalier Universitaire de STRASBOURG

    Strasbourg, 67098, France

  • Centre Hospitalier de La Cote Basque

    Bayonne, 64100, France

  • Centre Hospitalier du Mans

    Le Mans, 72000, France

  • Centre Hospitalier du Mont de Marsan

    Mont-de-Marsan, 40000, France

  • Chu Amiens

    Amiens, France

  • Clinique Victor Hugo

    Le Mans, 72000, France

  • Hopital Avicenne

    Bobigny, 9300, France

  • Hopital Nord Franche-Comté

    Belfort, 90015, France

  • Hopital Saint-Vincent de Paul

    Lille, 59160, France

  • Hopital St Louis T4

    Paris, 75475, France

  • Hôpital Henri-Mondor

    Créteil, 94010, France

  • Hôpital Morvan

    Brest, 29609, France

  • IPC

    Marseille, 13273, France

  • IUCT Oncopole

    Toulouse, 31059, France

  • Sophie Dimicoli-Salazar

    Pessac, 33604, France

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